Sharp H T, Williams P, Hatasaka H H, Poulson A M
Department of Obstetrics and Gynecology, University of Utah School of Medicine, 50 North Medical Drive, Salt Lake City, UT 84132, USA.
J Am Assoc Gynecol Laparosc. 1995 Feb;2(2):207-11. doi: 10.1016/s1074-3804(05)80019-2.
The ClearView Uterine Manipulator was compared with the Cohen acorn-tipped cannula for efficacy and safety in patients undergoing laparoscopy at the University of Utah Medical Center. Fifty consecutive patients were randomized by computer to have either the ClearView instrument or the Cohen cannula used as a uterine manipulator (25 patients each). The ClearView manipulator was statistically superior to the Cohen cannula for range of motion in the anterior and posterior sagittal plane (p <0.0001). The Cohen cannula was consistently inserted in less time (p <0.02). There was no statistically significant difference between the instruments in ease of uterine manipulation, ease of dye instillation, percentage of dye leakage from the cervix, overall ease of use, ease of device insertion, and ease of device removal. Two cervical perforations occurred during cervical dilatation in the ClearView manipulator group in patients with cervical stenosis requiring dilatation with metal dilators (os <2 mm). No patients in the Cohen cannula group had cervical stenosis. In that group two cervical lacerations occurred requiring suture ligation. The ClearView instrument provides a greater range of motion, does not require an assistant to maintain uterine position, and allows manipulation without a cervical tenaculum. Its insertion occasionally (36%) required tenaculum placement, uterine sounding, and cervical dilatation, increasing the time of insertion compared with placement of the Cohen cannula. In patients with cervical stenosis, use of a uterine sound and cervical dilatation increase the risk of perforation.
在犹他大学医学中心，对ClearView子宫操纵器和科恩橡子头套管在腹腔镜手术患者中的有效性和安全性进行了比较。连续50例患者通过计算机随机分组，分别使用ClearView器械或科恩套管作为子宫操纵器（每组25例患者）。在前后矢状面的活动范围方面，ClearView操纵器在统计学上优于科恩套管（p<0.0001）。科恩套管的插入时间始终较短（p<0.02）。在子宫操纵的难易程度、染料注入的难易程度、宫颈染料渗漏百分比、总体易用性、器械插入的难易程度以及器械取出的难易程度方面，两种器械之间没有统计学上的显著差异。在ClearView操纵器组中，两名宫颈狭窄患者在宫颈扩张过程中使用金属扩张器（宫颈口<2mm）时发生了宫颈穿孔。科恩套管组中没有患者患有宫颈狭窄。在该组中，发生了两例宫颈撕裂伤，需要进行缝合结扎。ClearView器械提供了更大的活动范围，不需要助手来维持子宫位置，并且在不使用宫颈钳的情况下即可进行操纵。与放置科恩套管相比，其插入偶尔（36%）需要放置宫颈钳、探测子宫和扩张宫颈，从而增加了插入时间。在宫颈狭窄患者中，使用子宫探子和扩张宫颈会增加穿孔的风险。
